Device and method for internal ligation of tubular structures

ABSTRACT

A surgical device for performing internal ligation of a fallopian tube or other tubular anatomical structure, by application of one or more ligating bands to a folded portion of the wall of the tubular structure. A method of using the device is also disclosed. The inventive method and device may be used for sterilization to prevent undesired pregnancies, or for other medical applications. One embodiment of the device includes an elongated tubular element that is inserted into the fallopian tube, a grasper that extends out of the tubular element, grasps the interior of the fallopian tube and retracts into the tubular element in a folded bundle of the fallopian tube tissue; and a pusher balloon for pushing a ligating band from the tip of the tubular element onto the tissue bundle. A fold assist mechanism may be included to help evert a section of a fallopian, or other, tube.

TECHNICAL FIELD

The present invention relates to methods for blocking tubular anatomicalstructures. In particular, the present invention relates to methods forligating the fallopian tube to achieve sterilization. The presentinvention pertains in addition to devices for performing tuballigations.

BACKGROUND

Occlusion of tubular anatomical structures is desirable for variousmedical treatments. One important application of occlusion techniques isblockage of the fallopian tubes in the female or vas deferens in themale to achieve sterilization and prevent undesired pregnancies.

Various methods for producing occlusion or blockage of tubularanatomical structures have been considered for contraceptive purposes. Acommonly used method for blocking the fallopian tube is to tie off orclamp the fallopian tube. The tube may be tied in two locations and theintermediate portion of tube removed. A similar result may be obtainedby grasping and folding over a portion of the tube and tying off a loopof tube that does not communicate with the remainder of the tube. Thefolded segment of tube may be blocked by a loop of suture material, aelastic ligating band or O-ring, or a clamp. Access to the fallopiantube is usually gained through endoscopic surgery, either through theabdominal wall or, less commonly, through the wall of the vagina. Suchmethods are less invasive than conventional surgical methods, but stillhave an undesirably high risk of infection and tissue damage, and areaccompanied by an undesirable recovery time and level of discomfort.

To eliminate the need for endoscopic or other, more invasive, surgery, anumber of approaches have been devised for blocking the lumen of thefallopian tube after accessing the interior of the fallopian tube byinserting a catheter into the lumen of the tube via the vagina anduterus.

One approach is to block the fallopian tube by injecting an adhesive orsealant, typically a polymeric material, into the fallopian tube to forma plug. Another approach is to insert a pre-formed occlusive device orplug into the lumen of the fallopian tube or the utero-tubal junction.However, either type of plug may separate or dislodge from the wall ofthe fallopian tube, resulting in unreliable or impermanent blockage.

Another approach for blocking the fallopian tube or other tubularanatomic structures is to induce the formation of sclerosis or scartissue to block the tube. Tissue damage may be induced chemically orthermally. However, this method is relatively difficult to accomplishsuccessfully and requires skilled personnel and specialized equipment,making it unsuited for use in certain settings.

Improvements over the prior art desirably will provide a method andsystem for applying a ligating structure to the interior of a tubularanatomical structure. Desirable improvements will cause a reliableocclusion of a tubular anatomical structure. Such occlusion of a tubularanatomical structure desirably is permanent in certain applications,such as in reproductive contraception. An inexpensive method foroccluding a tubular anatomical structure is also desired. An improvementmay provide a partially or completely disposable device for performingocclusion of a tubular anatomical structure. It would be a furtheradvance to provide an improved method for performing tubal ligationswhich requires only minimally invasive surgery, thereby reducing damageto vascular and reproductive tissues and reducing post-surgicaldiscomfort and recovery time. A method for performing tubal ligationswhich further reduces the risk of infection is also desirable.

BRIEF SUMMARY OF THE INVENTION

In accordance with the invention as embodied and broadly describedherein, a device is provided for applying ligating bands to tissue inthe interior of a tubular anatomical structures. The invention alsoincludes a method of using the device.

The device may be embodied as a surgical instrument for contraception offemale reproduction by occluding the fallopian tubes. Such a device hasa proximal and a distal end, the device being generally elongated andconfigured to permit insertion of the distal end into a fallopian tubevia the vagina and uterus, while the device is held and controlledexternal to the patient, at the proximal end.

The female contraceptive device generally includes an elongated tubehaving a central, longitudinally extending lumen and a grasper carriedon an end of an elongated member slidably disposed in the lumen. Thegrasper is capable of extending distally from the distal end of thetube, grasping tissue on the interior of a fallopian tube, andretracting proximally with the grasped tissue. Structure, includingactive mechanisms, may be provided at the distal end of the tube toassist in creating a circumferential fold, or an invagination of thefallopian tube, forming a tissue bundle or peduncle. One or moreligating bands are typically carried near the distal end of the tube. Aligating band may be released from the distal end of the tube tocontract as a sphincter about the tissue bundle and thereby occlude apassageway through the fallopian tube. One way to release a ligatingband is by driving the band distally, with a distal end of a sleeveslidably deployed around the tube, moving the band off from bandsupporting structure.

The proximal end of the device can be provided with a handle or base,and a number of controls thereon for controlling extension andretraction of the grasper with respect to the tube, actuation of thegrasper, and release of ligating bands onto a tissue bundle, among otheroperations. The device may be provided with a current source forsupplying current to cauterize tissue held by the grasper, or toseparate the grasper from an extension member. The device may also beprovided with an additional lumen for delivering drugs or othercompounds, such as antibiotics, topical anesthetics, or chemicalcauterizing agents, in the vicinity of the ligation.

A method of using the device includes the steps of inserting the distalend of the device into a tubular anatomical structure, causing thegrasper to extend distally out of the tube, grasping tissue in theinterior of the tubular anatomical structure with the grasper,retracting the grasper proximally, forming an inner tissue bundle, andreleasing a ligating band from the distal end of the tube to contract asa sphincter around the inner tissue bundle. The method may furtherinclude the steps of withdrawing the device to a new position within thetubular anatomical structure and repeating the preceding steps to applyone or more additional ligating bands.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In the drawings, which illustrate what are currently considered to bethe best modes for carrying out the invention:

FIG. 1 is a view of an embodiment of the device inserted into thefallopian tube of a patient, with the controls for the device shown inschematic form;

FIG. 2 is a perspective view of an embodiment of the device positionedin a fallopian tube, with the grasper shaft unextended;

FIG. 3 is a longitudinal cross-sectional view taken along line 3—3 inFIG. 2;

FIG. 4 shows an alternative pusher mechanism for releasing a ligatingband;

FIG. 5 is a transverse cross sectional view taken along line 5—5 in FIG.3;

FIG. 6 a perspective view of the device of FIGS. 2 through 5, showingthe balloon deflated and catheter extended;

FIG. 6.5 is a longitudinal cross section view of an alternativeembodiment of the device;

FIG. 6.6 is a perspective view of an embodiment of the device utilizingsuction tubes as graspers;

FIG. 7 depicts an alternative embodiment of the device tip having twoo-rings carried on the device and an alternative grasper;

FIG. 8 depicts a further alternative embodiment of the device tip havingtwo o-rings carried on the device and another alternative grasper;

FIG. 9 is a longitudinal cross-sectional view taken along line 9—9 inFIG. 6;

FIG. 10 is a longitudinal cross-sectional view of the device shown inFIGS. 2-9, depicting inflation of the balloon to force the barbs intothe wall of the fallopian tube;

FIG. 11 is a longitudinal cross-sectional view of the device showingdeflation of the balloon to draw the wall of the fallopian tube radiallyinward;

FIG. 12 is a longitudinal cross-sectional view of the device showingretraction of the grasper into the outer tube, drawing a fold of thefallopian tube with it into the outer tube;

FIG. 13 is a longitudinal cross-sectional view of the device showingexpansion of the pusher balloon to push the ligating band off the end ofthe outer tube and onto the fold of fallopian tube;

FIG. 14 is a longitudinal cross-sectional view of the ligated fallopiantube;

FIG. 15 is a longitudinal cross-sectional view of the fallopian tubefollowing application of a second ligating band;

FIG. 16 is a plan view of an alternate embodiment of the invention;

FIG. 17 is a longitudinal view, partially in section, of a tip portionof the device placed in a fallopian tube for tubal ligation;

FIG. 18 is a view similar to FIG. 17, but with the balloon expandedduring a preliminary stage of tubal ligation;

FIG. 19 is a view similar to FIG. 18, but with the balloon partiallyretracted proximally in an intermediate stage of tubal ligation;

FIG. 20 is a cross-section view similar to FIG. 19, but in aconfiguration near completion of tubal ligation.

BEST MODE OF THE INVENTION

FIG. 1 depicts one embodiment of the inventive device, generallyindicated at 20, for performing internal ligation of tubular structures.Device 20 includes an elongated tubular element 21 having a proximal end22 and distal end 23. Proximal end 22 of tubular element 21 is connectedto control segment 24, which includes controls 25, 26, 27, and 28 forcontrolling the device, and which also is used for supporting the deviceduring use. Control segment 24 may be configured as a handle to be heldin the hand of a person using device 20, or may be configured formounting on an examination table or other base. Device 20 is supportedand controlled by control segment 24 while distal end 23 is insertedinto the lumen 30 of fallopian tube 31 of a patient via the vagina 32,lumen 33 of uterus 34, and uterine horn 35. Ovaries 36 are also shown inFIG. 1. Proximal end 22 may include an access port 37 to permitinjection of anesthetics, antibiotics, or other substances into tubularelement 21 for infusion into the fallopian tube in the vicinity of theligation.

FIG. 2 shows detail of additional components of device 20 at distal end23 of tubular element 21, from circled region 2 in FIG. 1. Tubularelement 21 is shown positioned within the lumen 30 of fallopian tube 31,with the fallopian tube wall 39 shown in cross-section. Distal end 23 oftubular element 21 includes lip 40, on which is held a ligating band 41.Ligating band 41 may be of the type known for use in performing tuballigations, formed of rubber, silicone, and other suitable materials.Other ligating structures, such as suture loops or clamps, may be usedas well. Just proximal to ligating band 41 is pusher 42, which in thisexample is a pusher balloon having a generally toroidal shape. Pusherballoon 42 can be expanded distally to push ligating band 41 off thedistal end 23 of tubular element 21. The distal tip 43 of grasper shaft44 of grasper 38 is visible in lumen 45 of tubular element 21. Graspershaft 44 is shown in its unextended position, so that tip 43 does notproject significantly beyond the distal end 23 of tubular element 21.Grasper shaft 44 is preferably maintained in an unextended positionwhile device 20 is inserted into the fallopian tube of the patient.

FIG. 3 is a cross-sectional view of device 20 taken along section line3—3 in FIG. 2. Grasper 38 is slidably disposed in lumen 45 of tubularelement 21. In the embodiment of the invention shown here, grasper 38includes grasper shaft 44, which is hollow with a central lumen 50, andballoon 51, which is attached to grasper shaft 44. Lumen 50 of graspershaft 44 communicates with the interior 52 of balloon 51 via fluidchannels 53 a and 53 b. In use, balloon 51 is inflated to a selectedpressure or volume by the injection of a fluid with a syringe or otherpressurized source. In this context, fluid is intended to mean liquidsand gases. The fluid in grasper shaft 44 and the interior 52 of balloon51 could be, for example, air or saline. Balloon 51 may be inflated inthe same way as balloon angioplasty catheters. A plurality of barbs, ofwhich only 54 a and 54 b are visible in the present cross section, areattached to the exterior of balloon 51. Channels 46 a and 46 b intubular element 21 communicate with the interior 47 of pusher balloon42. Air or fluid from a syringe or other pressurized source connected atthe proximal ends of channels 46 a and 46 b is forced into pusherballoon 42 to cause it to expand and push ligating band 41 off of lip40.

FIG. 4 depicts an alternative embodiment of the invention in which apusher disk 48, driven by pusher rods 49 a and 49 b, is used in place ofpusher balloon 42. Pusher rods 49 a and 49 b are slidably disposed inchannels 46 a and 46 b and are driven by a mechanical actuator (notshown) located at the proximal end of the device, at control segment 24.Various actuation mechanisms may be devised by those of ordinary skillin the art for causing pusher rods 49 a and 49 b to move pusher disk 48to push ligating band 41 (not shown) off of band support structure atlip 40.

FIG. 5 is a transverse cross section taken at section line 5—5 in FIG.3. Channels 46 a and 46 b in tubular element 21 can be seen, as can asfluid channels 53 a, 53 b, 53 c, and 53 d, which provide fluidcommunication between grasper shaft lumen 50 and interior 52 of balloon51. Fluid channels 53 c and 53 d were not visible in the cross sectionshown in FIG. 3. Also, all of the plurality of barbs 54 a, 54 b, 54 c,etc., are visible in this cross section. Although two channels 46 a and46 b and four fluid channels 53 a, 53 b, 53 c, and 53 d are shown, thenumbers of channels are merely exemplary, and embodiments of the devicehaving different numbers of channels are considered to fall within thescope of the invention. Similarly, the number of barbs 54 a, 54 b, 54 c,etc., attached to balloon 51 may be varied.

FIG. 6, which depicts grasper shaft 44 extended out of the distal end 23of tubular element 21, more clearly shows the shape of balloon 51.Balloon 51 is generally cylindrical in shape, with its inner surfaceattached to the exterior of grasper shaft 44. A plurality of barbs 54 a,54 b, 54 c, etc., are attached to the exterior of balloon 51. As notedpreviously, when balloon 51 is inflated so that its outer diameter issubstantially equal to the diameter of lumen 30 of fallopian tube 31,barbs 54 a, 54 b, 54 c, etc. are forced into fallopian tube wall 39.Each barb has a shaft 90 that is attached to the exterior of balloon 51at a first end 91 and which has a tip 55 at second end 92 which allowsit to be readily pushed into the tissue of fallopian tube wall 39.Backward extending points 56 are attached at or near tip 55 and extendback toward first end 91 of shaft 90, and serve to engage the tissue toprevent withdrawal of the barb from the fallopian tube wall 39. Thesefeatures are specifically pointed out on barb 54 a, but all barbs 54 a,54 b, 54 c, etc. may include these features. The combination of balloon51 and barbs 54 a, 54 b, 54 c, etc. and grasper shaft 44 functiontogether as grasper 38.

FIG. 6.5 depicts a further alternative embodiment of the invention inwhich ligating band 41 is pushed off of distal end 23 of tubular element21 by sleeve 93, which is a tubular sleeve that is slidably disposedaround tubular element 21 and can be slid distally to push ligating band42 off of tubular element 21. In this and the other embodiments shownherein, ligating band 41 is released by being pushed off of distal end23 of tubular element 21. However, the invention is not limited toembodiments in which the ligating band or other ligating structure isreleased by being pushed. Other mechanisms for releasing a ligatingstructure may be devised, for example, tubular element 21 could beretracted within sleeve 93, so that ligating band 41 is maintained inplace while tubular element 21 is withdrawn from under it, thus allowingthe ligating band to contract onto a grasped tissue bundle. Further,other means for holding a ligating band or other ligating structure atthe end of tubular element 21 and then releasing it onto the graspedtissue bundle may be devised and are considered to fall within the scopeof the invention.

The embodiment of the invention shown in FIG. 6.5 also shows analternative version of grasper 38, in which the elongated catheterformed by grasper shaft 44 and balloon 51, as shown in FIGS. 3, 5 and 6,is replaced by an elongated catheter comprising inflatable catheter 95,which has a closed end 96 and interior lumen 97. Inflatable catheter 95is formed of a pliable material that is sufficiently elastic that whenthe pressure of the fluid in interior lumen 97 is increased, inflatablecatheter 95 inflates or balloons out at end region 98. When the pressureof the fluid in interior lumen 97 is reduced, end region 98 ofinflatable catheter 95 returns to its original diameter. Inflatablecatheter 97 is substantially functionally equivalent to the combinationof grasper shaft 44 and balloon 51 as shown in FIGS. 3, 5 and 6.

Also shown in FIG. 6.5 are hooked wires 100, which provide analternative hooking structure to the barbs used in the embodiment ofFIGS. 3, 5, and 6. Two can be seen in the cross section, but a pluralityof hooks (for example, four or five) would be used. When inflatablecatheter 95 is uninflated, hooked wires 100 conform to the exterior ofinflatable catheter 95, so inflatable catheter 95 and hooked wires 100fit inside tubular element 21. When inflatable catheter 95 is inflated,hooked wires 100 are splayed outward to be pushed into and grasp theinner wall of the fallopian tube (not shown). When inflatable catheter95 is deflated, hooked wires 100 return to their original position.

A further alternative grasper 38 is shown in FIG. 6.6. Inflatablecatheter 95 is as shown in FIG. 7, as is sleeve 93. Hooked wires 100shown in FIG. 6.5 are replaced by suction tubes 101, each of which hasan opening at or near its tip 102. In FIG. 6.6, openings 103 arepositioned laterally, and tip 102 is closed. When inflatable catheter 95is inflated, suction tubes 101 are urged outward to contact the wall ofthe fallopian tube (not shown). Generation of a vacuum in suction tubes101, from an external vacuum source connected to device 20 at controlsegment 24 and communicating with suction tubes 101, causes suctiontubes 101 to grasp the fallopian tube by drawing the tissue of thefallopian tube to opening 103 and holding it there for as long as thevacuum is maintained.

The inventive device may be constructed with various other alternativegrasper mechanisms. For example, a forceps-like mechanism could be usedto grasp tissue in the interior of the fallopian tube, or other graspermechanisms, for example, as shown in FIGS. 7 and 8, could be used. InFIG. 7, grasper 38 includes a grasper shaft 57 having a plurality ofhooks 58 a, 58 b, 58 c, and 58 d. In this embodiment of the invention,grasping is accomplished when one or more of hooks 58 a, 58 b, 58 c, and58 d catch on the wall of the fallopian tube. In the alternativeembodiment of the invention shown in FIG. 8, grasper 38 includes graspershaft 60 and a plurality of pivoting hooks 61 a and 61 b having angledpoints 62 a and 62 b. Pivoting hooks 61 a and 61 b would be held in aclosed position (shown in dashed lines) while grasper 38 was in itsretracted position in lumen 45 of tubular element 21, but when grasper38 was extended, pivoting hooks 61 a and 61 b would be moved to theiropen position (shown in solid lines) and then closed again to grasptissue on the interior of the fallopian tube. Pivoting hooks 61 a and 61b pivot on pivot points 63 a and 63 b, actuated by actuation mechanisms64 a and 64 b located in the lumen 65 of grasper shaft 60. Actuationmechanisms 64 a and 64 b could be, for example, drive rods which passthrough grasper shaft 60 to control segment 24, where they are moved bya lever or trigger mechanism.

FIGS. 7 and 8 feature illustrate another variation in the design of thedevice, as well. More than one ligating band may be held at distal end23 of tubular element 21, on lip 40 or in some other manner. In FIGS. 7and 8, two ligating bands 41 a and 41 b are shown, but a larger numbercould be used as well. As will be described in below, by providing twoligating bands 41 a and 41 b, it is possible to make two ligations in afallopian tube, in order to provide more reliable blockage of the tube.In order to release ligating bands 41 a and 41 b in sequence, pusherballoon 42 (in FIG. 7) or pusher disk 48 (in FIG. 8) must be extended afirst distance sufficient to push ligating band 41 a off lip 40, andthen be extended a second distance sufficient to push ligating band 41 boff lip 40. Pusher balloon 42 would be expanded to a first volume, andthen to a second, larger volume in order to push the two ligating bandssequentially. Similarly, pusher disk 48 would be extended to twodifferent positions sufficient to release ligating bands 41 a and 41 bsequentially. It would be possible to use the two ligating bands toperform ligation of the two fallopian tubes sequentially, with the samedevice, but this is not preferred, because the withdrawal of the devicefrom one fallopian tube, followed by reinsertion of the device into thesecond fallopian tube, provides an opportunity for contamination of thedevice and introduction of contaminants or infectious agents into theuterus or second fallopian tube.

It may be desirable to infuse antibiotics, topical anesthetics, or otherdrugs into the area of the ligation. Referring back to FIG. 2, drugs canbe infused from the tip 23 of tubular element 21 into fallopian tube 31.One or more drug delivery lumens may be provided. For example, lumen 45of tubular element 21 may function as a drug delivery lumen.Alternatively, one or more drug delivery lumens may be provided in thewall of tubular element 21, comparable to channels 46 a and 46 b shownin FIG. 5. As a further alternative, a drug delivery lumen may beprovided by adding a second tubular element surrounding, and coaxialwith tubular element 21, thereby forming a drug delivery lumen betweentubular element 21 and the second tubular element. Drugs would beinjected into the drug delivery lumen via access port 37, shown in FIG.1, which would be connected to the drug delivery lumen.

If desired, an electrical current may be passed through grasper 38 tocauterize the grasped tissue. For example, current could be passedthrough barbs 54 a, 54 b, 54 c, etc. of the device of FIGS. 2-6, hookedwires 100 of the device of FIG. 6.5, or through hooks 58 a, 58 b, 58 c,58 d or 61 a, 61 b, etc. of the grasper as shown in FIGS. 7 and 8.Cauterization of tissue may be of use to reduce bleeding and to burnaway small amounts of tissue to facilitate freeing of the fallopian tubefrom grasper 38. Cauterization of tissue may also be accomplished bydelivery of a chemical cauterizing agent through a drug delivery lumenas discussed above.

The method of using the inventive device includes the following steps,described in the context of ligation of a fallopian tube, but applicableto the ligation of other tubular anatomical structures, as well. In thediscussion of the methods steps, specific reference is made to theembodiment of the invention shown in FIGS. 1-3, 5 and 6, but the stepsmay be readily generalized to other embodiments of the invention.

1) INSERTION OF DEVICE. The first step is the insertion of the deviceinto the fallopian tube, as shown in FIGS. 1-3. The grasper 38maintained in the unextended position within tubular element 21 duringthe insertion step in order to prevent damage to the components ofgrasper 38 and to facilitate insertion of the device by having therelatively smooth, readily inserted distal end 23 of tubular element 21leading during insertion. Referring now to FIG. 1, a person performingthe procedure holds device 20 by control segment 24 and inserts distalend 23 into the vagina 31 of the patient, and then into the lumen 33 ofthe uterus 34. Distal end 23 is then guided into a uterine horn 35 andinto the lumen 30 of fallopian tube 31. Correct placement of distal end23 may be determined by monitoring the length of tubular element 22inserted after distal end 23 has passed the uterine horn 35 and enteredthe fallopian tube 31, as determined by change in resistance toinsertion. Insertion of tubular element 22 into uterus 34 and fallopiantube 31 may also be performed with hysteroscopic guidance. Device 20 mayinclude control wires (not shown) for steering distal end 23, or othersteering methods utilized with catheters, with steering control 25 oncontrol segment 24 used for steering distal end 23 during insertion.

2) EXTENSION OF GRASPER. As shown in FIGS. 6 and 9, once the distal end23 of tubular element 21 has been positioned properly within thefallopian tube 31, grasper 38 is extended out of tubular element 21.Grasper 38 is thus passed through the central opening of ligating band41. FIG. 9 is a cross-section of the device, taken along section line9—9 in FIG. 6. Extension and retraction of grasper shaft 44 may becontrolled by extension control 26 on control segment 24 in FIG. 1 whichmay be, for example, a trigger causing movement of a mechanical linkage.Various mechanisms may be devised for causing grasper shaft 44 to extendout of tubular element 21 by a predetermined distance, and the practiceof the invention is not limited to a particular mechanism.

3) GRASPING OF TISSUE. Once grasper 38 has been extended out of tubularelement 21, grasper 38 is activated to grasp tissue on the interior offallopian tube wall 39. Control segment 24, shown in FIG. 1, may includea grasp control 27 for controlling grasping. As shown in FIG. 8, balloon51 is inflated by fluid flowing through grasper shaft 44 until the outerdiameter of balloon 51 is substantially as large as the inner diameterof fallopian tube 31. Barbs 54 a, 54 b, etc. are then pushed into andgrasp or engage fallopian tube wall 39. Naturally, grasping of tissuecould also be accomplished with an alternative grasper mechanism, suchas those shown in FIGS. 6.5, 6.6, 7, and 8.

4) RETRACTION OF GRASPER SHAFT AND GRASPED TISSUE. As shown in FIG. 11,once tissue has been grasped by barbs 54 a, 54 b, etc., balloon 51 isdeflated, drawing the fallopian tube wall 39 radially inward towardgrasper shaft 44. Referring now to FIG. 12, following deflation ofballoon 51, grasper 38 is retracted into distal end 23 of tubularelement 21. A tissue bundle 70 from the fallopian tube wall 39, is drawninto distal end 23 of tubular element 21 by grasper 38. When tissuebundle 70 is drawn into distal end 23 of tubular element 21, it is atthe same time drawn through the central opening of ligating band 41.

5) RELEASING OF LIGATING BAND ONTO TISSUE BUNDLE. As shown in FIG. 13,ligating band 41 is pushed off of lip 40 by the expansion of pusherballoon 42. Pusher balloon 42 may be expanded by air or liquid, such aswater or saline solution, forced into pusher balloon 42 via channels 46a and 46 b. Once pushed off of lip 40, ligating band 41 contracts aroundtissue bundle 70. An alternative release mechanism, such as the pushermechanisms shown in FIG. 4 or 6.5, could be used at this step, instead.The pusher mechanism may be controlled by a push controller 28 locatedon control segment 24 in FIG. 1.

If tissue bundle 70 includes tissue from around the circumference of thetubular anatomical structure, application of ligating band 41 to tissuebundle 70 will produce blockage of fallopian tube 31. If, on the otherhand, tissue bundle 70 includes tissue from only one side of thefallopian tube 31, ligation of tissue bundle 70 will only separatetissue bundle 70 from the remainder of fallopian tube 31, but not blockfallopian tube 31. This may be desirable in certain medicalapplications, such as ligating damaged or cancerous tissue, but ofcourse would not be effective for contraception. A grasper which graspstissue around the circumference of the tube will form a tissue bundle 70that includes tissue from around the circumference of the tube. It mayalso be possible to form a tissue bundle that includes tissue fromaround the circumference of the tube by grasping tissue around only apart of the circumference of the tube, if the amount of tissue graspedis large enough that the stiffness of the tube causes the entirecircumference of the tube to fold in to form the tissue bundle.

6) FREEING OF GRASPED TISSUE. Following application of a ligating bandor bands, tissue bundle 70 must be freed from grasper 38. This may beaccomplished by simply tearing barbs 54 a, 54 b, etc. from tissue bundle70. Since tissue bundle 70 is separated from the main portion of thefallopian tube by the ligation, tissue damage caused by tearing out ofthe barbs is not of great concern. Cauterization of the tissue bypassing current through the barbs, hooks, or other portion of thegrasper contacting the tissue, or by delivering a chemical cauterizingagent, may facilitate freeing of tissue and reduce bleeding.

7) WITHDRAWAL OF DEVICE. Following ligation of tissue bundle 70 byligating band 41, and freeing of tissue bundle 70 from grasper 38, thedevice may be withdrawn. FIG. 14 shows the ligated fallopian tube 31,with tissue bundle 70 secured by ligating band 41. The lumen offallopian tube 31 is now divided into two sections separated by theligation: distal lumen 71, on the side closer to the ovary; and proximallumen 72, on the side closer to the uterus. If it is desired that only asingle ligating band be applied to the fallopian tube, the device is nowwithdrawn completely from the fallopian tube.

8) APPLICATION OF ADDITIONAL LIGATING BANDS. Referring now to FIG. 15,if it is desired that more than one ligating band be applied to thefallopian tube, after the application of first ligating band 41 a tofirst tissue bundle 70 a, tubular element 21 is withdrawn onlypartially, to a new, more proximal position within the fallopian tube,and steps 2 through 5 are repeated at the new, more proximal position,to apply second ligating band 41 b to second tissue bundle 70 b toproduce a double ligation. Lumen 72 is now between the first and secondligations, and lumen 73 is located most proximally on the side closer tothe uterus. Steps 6 through 8 may be repeated as many times as desiredto apply multiple ligating bands to one fallopian tube; however, it isanticipated that reliable ligation would be provided by one to threeligating bands, and larger numbers of ligating bands would not benecessary or desirable.

To accomplish sterilization, it is of course necessary to ligate bothfallopian tubes. Thus the procedure would be repeated for the secondtube in a similar manner. As noted above, it is preferred that the samedevice not be withdrawn from the first fallopian tube and thenreinserted into the second fallopian tube, due to the risk of infection.Therefore, two sterilized devices are preferably provided to performligation of both fallopian tubes. It is within contemplation tomanufacture the device having some or all components being disposable.

One alternate embodiment of the device, generally indicated at 200 inFIG. 16, is formed, in part, by three co-axial catheters 202, 204, and206, referenced in numerical order corresponding to increasing diameter.The device 200 has been designed for tubal ligation as an officeprocedure using locally applied topical anesthetics. Device 200 fitswithin the operating channel of a hysteroscope (2.2 mm ID), so thatstandard hysteroscopic techniques can be used to locate the fallopiantube opening (ostium) and feed the device 200 into the fallopian tube.

Placement of device 200 without hysteroscopic equipment may be effectedto provide non-surgical sterilization options for women in rural orunderdeveloped nations. Using a cannula bent at a 140° angle, the device200's tip is manually guided through the uterine horn and grosslypositioned near the utero tubal junction. The device 200 is then pushedfrom the cannula into the ostium and extended about 5 cm. Resistance toinsertion requires tip manipulation to search for the tubal openingwithin the minimal surface area at the cannula tip. Verification oftubal entry can be achieved via 20 ml saline instillation through thecatheter 204, where saline leakage into the cannula or cervical os isindicative of uterine (rather than tubal) catheter placement.

Catheters 202, 204, and 206 employed in devices 200 used forsterilization procedures desirably are formed from extruded nylon, orany other suitable medical grade polymer. The inner catheter 202 is anelongate member. The distal tip 208 of catheter 202 desirably isflexible and forms, or carries, an inflatable balloon 210. The distalend 212 of middle catheter 204 has an expandable tip, generallyindicated at 214, and also carries an O-ring 216. The outer catheter 206is used to push or deploy the O-ring 216 over an invaginated tissuepeduncle (tissue bundles 70 a and 70 b in FIG. 15). Handles orgrip-assisting structure, not illustrated, may be located on a proximal,or other convenient, location on each of catheters 202, 204, and 206, tofacilitate manipulation of the device 200 and its components.

The distal tip 220 of the device 200 desirably includes about a 1 cmlength of double hulled tubing 222. Tubing 222 desirably flexes toreduce the risk of tubal perforation during positioning of device 200,and also functions as an inflatable balloon 210 during a ligationprocedure. Tubing 222 may be made from Silastic tubing, or some otheroperable material.

A minimal volume of cyanoacrylate or other adhesive may be containedbetween the double hulls of a Silastic balloon 210, to function as agrasping aide. Cyanoacrylate is the adhesive of choice based upon itsminimal viscosity, long shelf life (in a dry environment) and ability tocure upon tissue contact. Several cyanoacrylate compounds are approvedfor human use, but Trufill™ (Cordis Neurovascular) is currently approvedfor internal (non-superficial) use. Since scaring side effects aredesirable for this application, the device 200 may not be limited tousing Trufill adhesive.

An inner hull of balloon 210 may be nonporous, with the outer hull, in arelaxed state, having pores sized small enough to prevent prematurepassage of the adhesive. A syringe 225 can be provided in a device 200to inflate the balloon 210. Other inflation devices are also operable.Inflation of the balloon 210 stretches the pores in the outer hull andallows local adhesive delivery through the pores in the outer balloonfor adhesion of the balloon 210 to an inside wall section of a tube tobe occluded. Pores in the outer hull may be arranged to produce spacedapart and axially aligned strips of adhesive on the balloon 210, tofacilitate collapse of an inflated and adhered balloon 210.

FIGS. 17-20 illustrate operation of the device during a ligationprocedure. In FIG. 17, distal tip 220 of device 200 has been inserted toa desired location for creation of an occlusion in a tube 230. Theoptimal sphincter location for female contraceptive ligation is justdistal to the ampullary-isthmic junction (4-5 cm from the ostium), wherethe inner diameter of the fallopian tube abruptly increases from about 2mm to about 5 mm. The ratio of wall thickness to inner diameter in theampullary tube makes this the first region that is appropriate forinvagination. Following positioning in the ampullary tube, the tip 214of catheter 204 is expanded to 5 mm, approximating the inner diameter ofthe fallopian tube. The device 200 is then drawn back (proximally) untilresistance to the expanded tip 214 prevents further withdrawal. Thisprocedure ensures appropriate positioning at the ampullary-isthmicjunction. FIG. 18 depicts inflation of balloon 210 to place adhesive incontact between the balloon 210 and an inner surface 232 of tube 230.Balloon 210 desirably is inflated with a formalin solution, such as 10%formalin. Furthermore, expandable tip 214 is illustrated in FIGS. 17 and18 as having a plurality of legs 235, each leg 235 being in asubstantially collapsed, or retracted, position for insertion into atube.

FIG. 19 illustrates proximal retraction of the balloon 210 with respectto a fold mechanism 237 formed, in part, from structure of expanding tip214. Fold mechanism 237 increases a diameter of tube 230, proximal to agrasped section, to assist in everting the tube 230. In the illustrateddevice 200, proximal retraction of balloon 210 simultaneously activatesfold mechanism 237. As shown in FIG. 20, a balloon 210 desirably iscollapsed to assist in forming a compact peduncle 250, although such isnot a requirement. FIG. 20 also shows catheter 206 has been advanceddistally to deploy O-ring 216 as a legator band around tissue bundle250. In some cases, a distal end of catheter 206 may additionally act asa passive fold assist mechanism, or to compact the peduncle 250.

After the O-ring is deployed, the tube 230 immediately is sealed for ashort term, at least until the peduncle 250 dies and its tissue sloughsoff. The balloon 210 may be pulled from its attachment, promoting localscarring to provide a long term occlusion of tube 230. At present it isdesired to leave balloon 210 attached, and for formalin leakage fromballoon 210 to promote scarring in the tube proximal the O-ring toprovide long term contraception. Permanent tubal occlusion is maintainedthrough the formation of scar tissue at the site of the ligationsphincter. Chronic exposure to the elastomeric ligature 216 causes asustained inflammatory response leading to more stable scar tissueformation. In addition, instillation of 10% formalin solution proximalto the tubal sphincter prevents epithelial regeneration and aids inpermanent scar formation. It is within contemplation alternatively, oradditionally, to provide a current source to cauterize tissue of thepeduncle and potentially to assist in separating a balloon 210 from acatheter 202. Alternatively, catheter 202 may be coupled to a balloon210 in a way preferentially to separate at a known weak link under agiven amount of tension in catheter 202.

Illustrated fold mechanism 237 includes a plurality of legs 235 spacedapart around a centerline, each leg 235 having a knee 239 between athigh 241 and a shin 243. A leg 235 desirably is sized such that a thigh241 will have an axial length equal to, or greater than, a correspondinglength of a shin 243. Such relative lengths assist in forming acircumferential fold in a wall of tube 230 during proximal retraction ofballoon 210. A thigh 241 longer than a shin 243 causes a wrap to form ina wall of tube 230, thereby everting proximal and distal tubularportions of tube 230, as the shin 239 is displaced rotatingly towardsthe thigh 241. A long thigh 241 also forms a ramp, or surface guide,assisting in deployment of O-ring 216. Although such is not currentlypreferred, it is within contemplation for a fold mechanism 237 to have asingle active component, such as a single leg 235.

Illustrated active fold mechanism 237 may be considered as forming oneor more four-bar linkages, and includes structure of catheter 202,expanding tip 214, and catheter 204. A distal portion of expanding tip214 is rotatably attached to a distal end of catheter 202. A proximaldisplacement of catheter 202, while holding catheter 204 fixed, causesknees 239 to buckle and deflect radially outward, expanding the tip 214and increasing a diameter of a localized portion of tube 230. In use,grasping structure, such as balloon 210, maintains (or even reduces) adiameter of a first tubular portion 245 of tube 230. A diameter of asecond, and proximal, tubular portion 249 of tube 230 is increased bythe transverse motion of knees 239. As illustrated in FIG. 20, thesecond portion 249 is folded over the first portion (everting the tube)to create a tissue bundle or peduncle 250.

An active mechanism generally can be defined as connected structurearranged actively to convert one form of work or a displacement in onedirection, to another form of work or displacement in a differentdirection. In the case of the illustrated fold mechanism 237, a proximal(axial) displacement of catheter 202 is actively converted to a radialdisplacement of knees 239. In turn, knees 239 expand a cross-section oftube 230 to an effective diameter larger than a diameter grasped by theballoon 210. Such an active mechanism 237 can be contrasted to theessentially fixed geometry of a passive fold assist mechanism, such as adistal end of catheter 206. The distal open end of catheter 206 mayassist in folding a tube 230, or in compacting a partially foldedpeduncle 250, but no active reduction in radial displacement occurs inthe catheter 206 itself. In fact, a distal end of catheter 206 may berequired to expand to accommodate insertion of a peduncle 250. In suchcase, thighs 241 may act as wedges to compact the diameter of a peduncle250.

Although hysterosalpingography can be used to confirm complete tubalocclusion, these procedures are expensive and typically not available indeveloping nations. An inexpensive alternative to visualization exploitsthe fact that the distal end of the fallopian tube is naturally open tothe peritoneal cavity. Following uterine injections of methylene blue,the dye dissipates into the peritoneal cavity then is processed andexcreted by the kidneys in less than 30 minutes. Only completelyoccluded tubes can prevent dye dispersion and excretion within this timeframe.

While the present invention has been described and illustrated in termsof certain specific embodiments, those of ordinary skill in the art willunderstand and appreciate that it is not so limited. Additions to,deletions from and modifications to these specific embodiments may beeffected without departing from the scope of the invention as defined bythe claims. Furthermore, features and elements from one specificembodiment may be likewise applied to another embodiment withoutdeparting from the scope of the invention as defined herein.

What is claimed is:
 1. A method for blocking a passageway through atubular anatomical structure, comprising the steps of: grasping tissueon the interior of said tubular anatomical structure with a grasper,said grasper being carried at a distal end of an elongate member;proximally retracting said grasper with respect to a fold mechanismoperable to increase a diameter of said tubular anatomical structure ata location proximal to said grasper; activating said fold mechanism toassist in formation of a tissue bundle comprising tissue from around theentire circumference of said tubular anatomical structure; and applyinga ligating structure to said tissue bundle to block said passageway. 2.The method according to claim 1, wherein said fold mechanism comprises atoggling leg having a knee adapted for radial translation to expand afirst cross-section of said tubular anatomical structure, to a diameterlarger than a diameter of a second cross-section of said tubularanatomical structure at a location being grasped by said grasper, so asto assist in forming a circumferential fold in said tubular anatomicalstructure when said grasper is proximally retracted with respect to saidfold mechanism.
 3. The method according to claim 2, wherein said grasperand said fold mechanism are cooperatively structured such that proximalretraction of said grasper simultaneously activates said fold mechanism.4. The method according to claim 3, said fold mechanism being configuredand arranged to assist in everting a first tubular section of saidtubular anatomical structure, located adjacent and proximal to a secondtubular section being grasped by said grasper, such that a vector,originating at one end and following a centerline of said tubularanatomical structure, is substantially coaxial, but reversed indirection, between said first and second tubular sections.
 5. The methodaccording to claim 1, said grasper comprising an inflatable section, themethod further comprising the step of inflating said inflatable sectionwhereby to adhere a portion of said inflatable section, carrying anadhesive, to a section of said tubular anatomical structure to performsaid grasping.
 6. The method according to claim 1, further comprisingthe step of detaching said grasper from said distal end of said elongatemember, and removing said elongate member from inside said tubularanatomical structure.
 7. A device for everting a first tubular sectionof a tubular anatomical structure to form a tissue bundle and applyingat least one ligating structure to said tissue bundle, comprising: anelongated conduit comprising a distal end, a proximal end, and a lumentherebetween, wherein said distal end is adapted for insertion into saidtubular anatomical structure; a grasper carried at a distal end of anelongate member, said elongate member being slidably disposed withinsaid lumen, said grasper being capable of extending distally from saidconduit, grasping grasped tissue on the interior of said tubularanatomical structure, and retracting proximally with said graspedtissue; an active fold mechanism configured and arranged to assist saidgrasper in everting said first tubular section; a ligating structurereleasably carried near a distal end of said device; and applicationstructure disposed near said distal end of said conduit and adapted forapplying said ligating structure to said tissue bundle.
 8. The device ofclaim 7, wherein said grasper comprises a balloon structure disposablefor inflation distal to said fold mechanism.
 9. The device of claim 8,wherein said grasper further comprises an adhesive substance beingreleased, by inflation of said balloon, to form an adhesive layerbetween said balloon and said grasped tissue.
 10. The device of claim 9,wherein said balloon comprises a dual walled inflation structure havingouter and inner walls with an adhesive substance disposed between saidouter and inner walls, said outer wall of said inflation structurehaving pores being expandable on inflation of said balloon to permitpassage through said expanded pores by said adhesive substance.
 11. Thedevice of claim 7, said fold mechanism comprising: a leg having a kneeadapted for radial translation to expand a first cross-section of saidtubular anatomical structure, to a diameter larger than a diameter of asecond cross-section of said tubular anatomical structure at a locationbeing grasped by said grasper, whereby to assist in forming acircumferential fold in said tubular anatomical structure when saidgrasper is retracted proximally with respect to said fold mechanism. 12.The device of claim 11, wherein said leg comprises a shin portion distalto said knee; and a thigh portion proximal to said knee.
 13. The deviceof claim 12, wherein said shin portion and said thigh portion areapproximately of the same length.
 14. The device of claim 12, whereinsaid shin portion having a length shorter than a length of a thighportion, whereby to cause a first, outward, radial displacement of saidknee, and a second, inward, radial translation of said knee as saidgrasper is moved proximally from a grasp engaging position to a foldedposition.
 15. The device of claim 11, comprising a plurality of togglinglegs, each leg having a knee, said legs being arranged to provide aplurality of knees spaced apart around a centerline and arranged inharmony for common action of said plurality of knees to expand saidfirst cross-section.
 16. The device of claim 7, said applicationstructure comprising a portion of said distal end of said conduit. 17.The device of claim 7, wherein said ligating structure comprises aresilient O-ring.
 18. A device for blocking a passageway of a flexibletube, at an internal and intermediate location between ends of the tube,comprising: a conduit comprising a distal end, a proximal end, and alumen therebetween, said distal end being adapted for insertion into oneopen end of said tube; a balloon comprising a dual walled inflationstructure having outer and inner walls with an adhesive substancedisposed between said outer and inner walls, said outer wall of saidinflation structure having pores being expandable on inflation of saidballoon to permit passage through expanded said pores by said adhesivesubstance; an elongate member with a distal end adapted to carry saidballoon, said elongate member being slidably disposed within said lumen,said balloon being capable of extending distally from said conduit,inflating to create an adhesive grasp on a first tube section of theinterior of said tube, and retracting proximally with said first tubesection; a ligating structure releasably carried near a distal end ofsaid device; and application structure disposed near said distal end ofsaid conduit and adapted for applying said ligating structure to blocksaid passageway.
 19. The device of claim 18, further comprising: a foldassisting structure located, configured, and arranged to assist saidballoon in everting a section of said tube.
 20. The device of claim 19,said fold assisting structure comprising a mechanism operable toincrease a diameter of a second tube section at a location proximal tosaid first tube section, thereby permitting said first tube section tobe retracted proximally to a concentric position within said second tubesection to create a circumferential fold in said tube and a resultingtissue peduncle.
 21. The device according to claim 20, said mechanismcomprising: a plurality of legs, each leg having a knee, said legs beingarranged to provide a plurality of knees spaced apart around acenterline and arranged in harmony for radial translation of saidplurality of knees to increase a diameter of said second tube section.22. A method for blocking a passageway in a tubular anatomicalstructure, said method comprising: grasping the tubular anatomicalstructure's interior tissue with a grasper, said grasper being carriedat a distal end of an elongate member; proximally retracting saidgrasper with respect to a toggling leg having a knee adapted for radialtranslation to expand a first cross-section of the tubular anatomicalstructure, to a diameter larger than a diameter of a secondcross-section of the tubular anatomical structure at a location beinggrasped by said grasper, so as to assist in forming a circumferentialfold in the tubular anatomical structure; activating said toggling legto assist in formation of a tissue bundle; and applying a ligatingstructure to the tissue bundle to block the passageway.
 23. The methodaccording to claim 22, wherein said grasper and said toggling leg arecooperatively structured such that proximal retraction of said graspersimultaneously activates said toggling leg.
 24. The method according toclaim 23, wherein said toggling leg is configured and arranged to assistin everting a first tubular section of the tubular anatomical structure,located adjacent and proximal to a second tubular section being graspedby said grasper, such that a vector, originating at one end andfollowing a centerline of the tubular anatomical structure, issubstantially coaxial, but reversed in direction, between said first andsecond tubular sections.
 25. A method for blocking a passageway in atubular anatomical structure, said method comprising: inflating aninflatable grasper to adhere a portion of said inflatable grasper,carrying an adhesive, to a section of the tubular anatomical structureto grasp tissue on the interior of the tubular anatomical structure,said inflatable grasper being carried at a distal end of an elongatemember; proximally retracting said inflatable grasper with respect to afold mechanism operable to increase a diameter of the tubular anatomicalstructure at a location proximal to said inflatable grasper; activatingsaid fold mechanism to assist in formation of a tissue bundle comprisingtissue from around the entire circumference of the tubular anatomicalstructure; and applying a ligating structure to the tissue bundle toblock the passageway.
 26. A method for blocking a passageway in atubular anatomical structure, said method comprising: grasping tissue onthe interior of the tubular anatomical structure with a grasper, saidgrasper being carried at a distal end of an elongate member; proximallyretracting said grasper with respect to a fold mechanism operable toincrease a diameter of the tubular anatomical structure at a locationproximal to said grasper; activating said fold mechanism to assist information of a tissue bundle comprising tissue from around the entirecircumference of the tubular anatomical structure; applying a ligatingstructure to the tissue bundle to block the passageway; and detachingsaid grasper from said distal end of said elongate member.